Airflow visualization studies are used to observe air movement, which can reduce the risk to the process and/or product. The results from these studies can be used to develop and/or enhance filling operations to ensure global regulatory requirements are met. They can also be used as a training tool for personnel, as well as define the sanitization procedures and environmental monitoring process within the aseptic filling areas.
In this course, participants will discuss the components required in an airflow visualization study, to include:
- Protocol design
- Static, dynamic and as built conditions
- Fill equipment set-up
- Intervention execution
- Personnel movements
- Air return balancing
- Protocol acceptance criteria
Participants will also learn about the regulatory requirements, facility design elements, HEPA filter operations and fill room air return designs. The key element to the airflow study is the concept of “First Air” and its relationship to product sterility and risk reduction. Participants will learn how to incorporate these elements into a contamination control program emphasizing good aseptic technique and cleanroom behavior.
Participants will get the opportunity to execute both static and dynamic airflow studies, film the process, critique the video and assess their results. They will also learn how to visually document their study in a way that allows the viewer to clearly understand the process based on the risk and “First Air” concept.
Who Should Attend
Department: Engineering, Manufacturing, Microbiology, Quality, Training, Validation
Job Function: Auditors, Directors, Managers, Leaders, Supervisors, Engineers, Site Head, Plant Manager, Qualified Person